National Retrospective Study of Duodenal Trauma

NCT06058975 | Completed

• 1 other identifier: 23Urgences02
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

Duodenal injuries remain rare among abdominal trauma, concerning less than 5 % of cases. However, due to its central location, it is most commonly associated with multiple organs lesions, with the main three organs being the liver, the colon and the pancreas. Additionally, the penetrating mechanism is four times more common than blunt trauma and the most common duodenal site of injury is the second portion (36 %), the least being the first duodenum (13 %). These particularities generate a high morbidity, ranging from 22 to 27.1 %, and a mortality still as high as 5.3 to 30 % today. When facing it, surgeons are usually challenged in their strategy. Indeed, when surgery is required, different options can be chosen depending on the grade of the lesion and the involvement of the papilla and/or other organs. Primary repairs, duodenal diverticulization, pyloric exclusion, gastrojejunostomy, retrograde duodenostomy, distal feeding tube, or even resection and Whipple procedures, have all been described. Since the classification of the American Association for the surgery of trauma (AAST), most studies stratified their management as such: drainage only or primary repair for grade 1 and 2, jejunostomy and/or pyloric exclusion for grade 3, Whipple for grade 4 or 5. However, reviews of the literature aren't clear if this decisional tree is in correlation with lower morbidities, and often different procedures have been reported for the same grade. The escalation of technical exclusions among severe grades became controversial. As an example, pyloric exclusion has been criticized in its preventive role of protecting the suture, being useless at least, or even worse at times. Thus, in the recent years, the management has been focused towards minimization. Indeed, in the retrospective review of the Pan-American trauma society primary repair alone was performed in 80 % of cases, all grades comprised. Although mortality was high, duodenal suture line leak was statistically lower among survivors over every grade. To clear the situation, prospective studies are difficult if not impossible in such context. Thus, The investigators propose this national benchmark, to retrospectively review in France the management of duodenal trauma, depending on the grade, and its associated morbidity.

Conditions

Duodenal Diverticulization; Pyloric Exclusion; Gastrojejunostomy; Retrograde Duodenostomy; Distal Feeding Tube; Resection and Whipple Procedures; Primary Repairs

Outcome Measures

Primary Outcomes (2)

• Overall mortality

  Study mortality is overall mortality, not specific to abdominal trauma. It corresponds to grade 5 of the Clavien-Dindo classification.

  1 month after trauma

• Specific mortality

  Specific mortality is the mortality due to abdominal trauma, including abdominal compartment syndrome, coagulopathy, hemorrhage, multi-organ failure, etc. It excludes brain death, mortality due to trauma of other body regions. It corresponds to grade 5 of the Clavien-Dindo classification.

  1 month after trauma

Secondary Outcomes (3)

• Severe morbidity

  3 months after trauma

• Kind of treatment: medical, endoscopic or surgical

  The first 3 months after trauma

• type of injury of the duodenum

  no later than the 7th day after the trauma

Interventions

Observational OTHER

Review the management of duodenal trauma in France

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with duodenal trauma

You may qualify if:

• patients with duodenal trauma,
• older than 18 years old.

You may not qualify if:

• pregnancy
• previous duodenal surgery.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, Alpes Maritimes, 06000, France

Location

Related Publications (1)

• Frey S, Bentellis I, Gaujoux S, Girard E, Abba J, Chirica M, Bertrand M, Boutry E, Mege D, Aubert M, Alves A, Hornez E, Mulliri A, Brustia R, Hentati H, Lauka L, Laurent A, Sommacale D, Turco C, Dezeustre M, Bajul M, Castel A, Facy O, Grellet R, Sulpice L, Menegaux F, Delestre M, Lermite E, Monchal T, Amrou R, Bacoeur-Ouzillou O, Pezet D, Bonnet J, Buc E, Passot G, Schneck AS, Birnbaum DJ, Blanc PY, Le Roy B, Monneuse O, Rodriguez Q, Suc B, Baque P, Dubuisson V, Massalou D. How are duodenal trauma managed? A French nationwide study. World J Emerg Surg. 2025 Dec 9;20(1):89. doi: 10.1186/s13017-025-00661-z.

  PMID: 41366408 DERIVED

MeSH Terms

Interventions

Watchful Waiting

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: September 28, 2023
• Study Start: January 8, 2023
• Primary Completion: September 30, 2023
• Study Completion: December 31, 2024
• Last Updated: April 2, 2025

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)